Reason for the recall
- The product presents a risk of strangulation as a vulnerable individual may slide downward in a wheelchair or armchair while restrained by the lap belt, causing the belt to shift and restrict the neck.
Reasonsee the original notice
BrandORTONES
Batch number(s)not stated
Barcodenot stated
Product
- Summary
- Product: ORTONES Wheelchair and Geriatric Arm Chair Lap Belt sold via Amazon
- Hazard: The product presents a risk of strangulation as a vulnerable individual may slide downward in a wheelchair or armchair while restrained by the lap belt, causing the belt to shift and restrict the neck.
- Corrective action: The product has been withdrawn from the UK market and warnings issued to consumers.
- Product information
- Type
- Lap/Support Belt for Wheelchair User
- Brand
- ORTONES
- Model
- D2100
- Country of Origin
- Unknown
- Product Description
- Abdominal fabric belt designed to provide support to users of a wheelchair, geriatric chair or armchair.
- Product Report and Image
- Link to product image and PDF
- Hazard
- The product presents a risk of strangulation. A vulnerable individual may slide downward in a wheelchair or armchair while restrained by the lap belt, causing the belt to shift and constrict the neck.
- Without proper fitting, supervision or training, this can result in positional asphyxiation, strangulation, or falling from the seat and becoming injured, particularly if the user is unattended and/or unable to self-rescue.
- The Medicines and Healthcare products Regulatory Agency (MHRA) previously issued an Alert for this type of product, which contains further information on actions that should be taken: Medical Device Alert
- The product does not meet the requirements of the General Product Safety Regulations 2005.
- Corrective action
- The product has been withdrawn from the UK market by the manufacturer. An updated instruction manual has been issued to consumers, warning of the risks presented by the product.
- Owners of the ORTONES belt are advised by the manufacturer to ensure that the belt should be used only under the supervision or prescription of a health professional or specialist technician. The manufacturer warns that the product is not suitable for users who do not have good body control when seated, and that a health care professional should be consulted before using the belt if the owner has respiratory or cardiac problems.
- OPSS advises that owners of similar products ensure that they can be safely used in accordance with the manufacturer’s instructions, under the appropriate supervision and prescription of a health care professional.
- Additional information
- PSD notification number: 2510-0031
- Notified by: Office for Product Safety and Standards
What to do
- The product has been withdrawn from the UK market and warnings issued to consumers.
- Product information
- Type
- Lap/Support Belt for Wheelchair User
Source: Product Safety Alerts, Reports and Recalls (OPSS) — Office for Product Safety and Standards (OPSS)
Source: Office for Product Safety and Standards, GOV.UK. Contains public sector information licensed under the Open Government Licence v3.0. EU Safety Radar is an independent information service; the text above presents the official data in the original language — the notice published by the authority is authoritative.
Open the original notice (www.gov.uk) ↗ Official document (PDF) ↗